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A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi

NCT05385068 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-05-23

No results posted yet for this study

Summary

This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).

Conditions

  • Epithelial Ovarian Cancer

Interventions

DRUG

Niraparib

Niraparib 200 or 300mg\* QD PO continually; \*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL. For patients who had experienced grade 4 adverse events from previous use of PARPi, niraparib staring dose was 200 mg QD. Anlotinib 10mg QD PO from Day 1 to 14 of every 21-day cycle

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-03-31
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385068 on ClinicalTrials.gov